Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/02/2005
Date assigned
25/07/2005
Last edited
12/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert Andrews

ORCID ID

Contact details

Joint Clinical Research Unit
Level 5
Old Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 9282440
rob.andrews@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

The Early ACTID Study

Study hypothesis

An ideal treatment for diabetes would improve glycaemic control by decreasing insulin resistance and improving insulin secretion without the side effect of weight gain. To date no pharmacological agents have been able to satisfy all of these criteria. In contrast, increased physical activity has the potential to offer all of these benefits with little or no side-effects. Hence it should represent the ideal first line treatment for Type 2 diabetes and for maximal benefit should be instituted early. Whilst we know that lifestyle intervention can be an effective treatment for those individuals with impaired glucose tolerance, i.e. in a pre-diabetic state, what we seek to establish is whether increased physical activity (using a simple home-based exercise programme) and dietary changes can alter the course of established type 2 diabetes.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Type 2 diabetes

Intervention

1. Intensive dietary intervention
2. Increased exercise and intensive dietary intervention
3. Control: Usual Care

Individuals recruited into all 3 arms of the trial will have their diabetes and blood pressure management taken over by Early ACTID for the duration of the trial. Both intervention arms are based on regular counselling sessions with a research nurse and/or dietitian to encourage changes to the patients lifestyle.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Glycaemic control as measured by HbA1c and systolic and diastolic blood pressure, at 6 months.

Secondary outcome measures

Lipids, insulin resistance, weight/body composition, and amount of medication required to control diabetes and blood pressure at 12 months.

Overall trial start date

01/07/2005

Overall trial end date

31/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

This a multicentre trial recruiting 750 participants from across the South West of England. Individuals must satisfy the following criteria before they can be considered eligible:
1. Type 2 diabetes mellitus (T2DM) as defined by: body mass index (BMI) >25, no ketosis, no significant weight loss prior to diagnosis, aged above 30 at diagnosis
2. Between 5 and 8 months from clinical diagnosis of T2DM

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

750

Participant exclusion criteria

1. Age over 80 at diagnosis
2. HbA1c of greater than 10%
3. Blood pressure greater than 180/100
4. Low-density lipoprotein (LDL) greater than 4
5. Patients already receiving a maximum dose of a sulphonylurea
6. Have a current diagnosis of unstable angina
7. Have had a myocardial infarction within the previous three months
8. Unable to increase their physical activity
9. Subject is pregnant or is of childbearing age and not surgically sterile, 2 years postmenopausal or does not practice one method of contraception

Recruitment start date

01/07/2005

Recruitment end date

31/07/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Joint Clinical Research Unit
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Gillian Tallents
Research Governance Manager
University of Bristol
Research & Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS2 8HW
United Kingdom
+44 (0)117 9546966
Gillian.Tallents@bristol.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Diabetes UK (UK) (ref: BDA:R04/0002750)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

National Health Service (NHS) (UK) - ad hoc funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21705068
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24811615

Publication citations

  1. Results

    Andrews RC, Cooper AR, Montgomery AA, Norcross AJ, Peters TJ, Sharp DJ, Jackson N, Fitzsimons K, Bright J, Coulman K, England CY, Gorton J, McLenaghan A, Paxton E, Polet A, Thompson C, Dayan CM, Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial., Lancet, 2011, 378, 9786, 129-139, doi: 10.1016/S0140-6736(11)60442-X.

  2. Results

    Thompson D, Walhin JP, Batterham AM, Stokes KA, Cooper AR, Andrews RC, Effect of diet or diet plus physical activity versus usual care on inflammatory markers in patients with newly diagnosed type 2 diabetes: the Early ACTivity In Diabetes (ACTID) randomized, controlled trial., J Am Heart Assoc, 2014, 3, 3, e000828, doi: 10.1161/JAHA.114.000828.

Additional files

Editorial Notes